BACTON TM, BASIC TM, APO A-I REAGENT
Device Facts
| Record ID | K893885 |
|---|---|
| Device Name | BACTON TM, BASIC TM, APO A-I REAGENT |
| Applicant | Catachem, Inc. |
| Product Code | DEL · Immunology |
| Decision Date | Jun 21, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5590 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A lipoprotein X immunological test system is a device that consists of the reagents used to measure by immunochemical techniques lipoprotein X (a high-density lipoprotein) in serum and other body fluids. Measurement of lipoprotein X aids in the diagnosis of obstructive liver disease.
